[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555461":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":30,"locations":37,"responsibleParty":55,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":25,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":25,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":75,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Centre for Addiction and Mental Health","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cannabidiol","EXPERIMENTAL","10-day supply of 600 mg of CBD, taken orally twice daily",[13],"Drug: Oral solution",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","10-day supply of 600 mg of placebo, taken orally twice daily",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Oral solution","300 mg taken morning and evening",[9,15],null,[27],{"name":28,"affiliation":5,"role":29},"Matthew Sloan, MD","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Kelly Xiao, MSc","CONTACT","416-535-8501","32447","kelly.xiao@camh.ca",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Toronto","Ontario","M6J 1H4","Canada","CA",{"type":46,"coordinates":47},"Point",[48,49],-79.39864,43.70643,{"lat":49,"lon":48},[52,53],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},{"name":54,"role":29,"phone":25,"phoneExt":25,"email":25},"Matthew E Sloan, MD",{"type":56,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100555461","phase-2-evaluating-cannabidiol-as-a-novel-anticraving-medication-for-alcohol-use-disorder-100555461",false,"NCT06512389","Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder","Evaluating Cannabidiol as a Novel Anticraving Medication for Alcohol Use Disorder: A Human Laboratory Study","Inclusion Criteria:\n\n* Meets DSM-5 criteria for AUD.\n* Meets drinking criteria of average weekly consumption \\> 10 standard drinks for women and \\> 15 standard drinks for men over the past 90 days.\n* Willing to take study medication and participate in laboratory sessions requiring self-administration of alcohol\n* Agrees not to use cannabis or illicit drugs during the study period.\n* Able to communicate and provide informed consent in English.\n* Alanine Aminotransferase (ALT) and Aspartate Transaminase (AST) level should not be more than 2 times the upper normal limit, and bilirubin should not be more than 1.5 times the upper normal limit.\n* Enrolled in the Ontario Health Insurance Plan (OHIP)\n* Willing and able to safely abstain from alcohol for at least 12 hours prior to the eligibility and alcohol self-administration visit.\n* Individuals who are capable of becoming pregnant: agree to the use of highly effective contraception during study participation and for an additional 28 days after the end of cannabidiol administration.\n\nExclusion Criteria:\n\n* Clinical Institute Withdrawal Assessment (CIWA-Ar) score of 10 or above upon initial assessment\n* History of severe alcohol withdrawal including withdrawal seizures, alcoholic hallucinosis, or delirium tremens\n* Any history of seizures\n* Serious unstable medical condition, including severe hepatic abnormalities\n* Having any clinical condition, drug sensitivity, or prior therapy which, in the investigator's opinion, makes the participant unsuitable for the study\n* Current medical conditions, prescriptions, or over the counter medications that interfere with receiving the study drug or alcohol (based on the study physician's assessment)\n* Severe mental illness (e.g. active psychosis with ongoing delusions and\u002For hallucinations, active manic or hypomanic episodes, evidence of a major neurocognitive disorder, etc.) and other substance use disorders (moderate or severe; excluding tobacco use disorder) as determined by the qualified investigator\n* Experiencing active suicidal ideation within the past 1 month and\u002For suicide attempt within the past 6 months\n* Recent recreational drug use (assessed via urine toxicology screen) other than alcohol and nicotine products\n* Current use of CBD products or use of CBD products within the past month.\n* History of hypersensitivity to CBD\n* Self-report of significant alcohol-induced flushing after 1-2 drinks (a proxy for aldehyde dehydrogenase deficiency)\n* Currently pregnant or breastfeeding or intending to become pregnant or breastfeed.\n* Currently institutionalized which refers to a person who lives in an institutional collective dwelling, such as a hospital, nursing home or prison, including a resident under custody (e.g., patient or inmate).\n* Currently in treatment for AUD (e.g. Alcoholics Anonymous, group therapy, individual therapy, on anticraving medication)","ALL","19 Years",{"count":67,"type":68},36,"ESTIMATED","INTERVENTIONAL",[71],"PHASE2","This human laboratory study aims to assess the effects of cannabidiol on alcohol consumption and craving in participants with alcohol use disorder. In this double-blind within-subject placebo-controlled crossover trial, participants will be randomized to receive both cannabidiol and placebo with a 2-week washout period separating the two treatment phases.",[74],"Alcohol Use Disorder",[76,77,78,79],"alcohol use disorder","cannabidiol","alcohol consumption","craving","2026-03-19",{"date":82,"type":83},"2026-03-20","ACTUAL",{"date":85,"type":83},"2024-08-16",{"date":87,"type":68},"2026-06-30",{"name":5,"class":6},1]